EMA – Page 225 – Pharma.Tips

Homogeneity Failure during scale-up: mixing, sampling, and hold-time controls

Understanding Homogeneity Issues During Scale-Up: Investigating Mixing, Sampling, and Hold-Time Controls Homogeneity failures in pharmaceutical manufacturing, particularly during the scale-up of liquid oral dosage forms, present significant challenges to quality…

Density Mismatch in oral suspension manufacturing: investigation flowchart aligned to GMP

Investigating Density Mismatch in Oral Suspension Manufacturing In the pharmaceutical manufacturing landscape, ensuring the correct density of oral suspensions is critical for product safety and efficacy. Density mismatch can lead…

Preservative Under-Dosing during filling line setup: manufacturing vs lab root cause decision tree

Analyzing Preservative Under-Dosing during Filling Line Setup: A Root Cause Investigation Approach In pharmaceutical manufacturing, the integrity of liquid oral dosage forms is paramount, especially in products requiring preservatives for…

Hold Time Bioburden Rise at accelerated stability: packaging and transport risk assessment

Investigating Hold Time Bioburden Elevations During Accelerated Stability Studies In the realm of pharmaceutical manufacturing, an unexpected rise in bioburden during hold time at accelerated stability conditions can pose significant…

Homogeneity Failure after supplier change: how QA should write CAPA for inspectors

Managing Homogeneity Failures Post-Supplier Change: A Guide for Quality Assurance In the realm of pharmaceutical manufacturing, ensuring product homogeneity is crucial for both compliance and therapeutic efficacy. A common issue…

Crystallization In Syrup after supplier change: water system and sanitation checks

Identifying and Addressing Crystallization in Syrups Following Supplier Changes In the pharmaceutical manufacturing landscape, the integrity of liquid oral dosage forms, such as syrups, is paramount. A recent challenge arises…

Preservative Under-Dosing during method transfer: manufacturing vs lab root cause decision tree

Understanding the Root Cause of Preservative Under-Dosing during Method Transfer in Pharmaceutical Manufacturing In pharmaceutical manufacturing, particularly within liquid oral dosage forms such as syrups and suspensions, the precision of…

Homogeneity Failure after supplier change: water system and sanitation checks

Dealing with Homogeneity Issues after Supplier Transition: An Investigation Framework In pharmaceutical manufacturing, supplier changes can introduce variability that may lead to significant product quality issues, including homogeneity failures. Such…

Fill Volume Variability after temperature excursion: manufacturing vs lab root cause decision tree

Investigating Fill Volume Variability After Temperature Excursion: A Manufacturing and Lab Decision Tree Fill volume variability can lead to significant compliance issues within pharmaceutical manufacturing, especially following a temperature excursion.…

Hold Time Bioburden Rise during scale-up: water system and sanitation checks

Investigating the Rise of Hold Time Bioburden during Scale-up: Essential Checks for Water Systems and Sanitation In the realm of pharmaceutical manufacturing, the rise of bioburden during hold times poses…

Crystallization In Syrup in syrup production: packaging and transport risk assessment

Assessing Risks of Crystallization in Syrup Production: An Investigation Framework In the pharmaceutical manufacturing of liquid oral dosage forms, particularly syrups, the occurrence of crystallization poses significant challenges. These challenges…

Homogeneity Failure during method transfer: manufacturing vs lab root cause decision tree

Decision Tree for Investigating Homogeneity Failure during Method Transfer in Pharmaceutical Manufacturing In pharmaceutical manufacturing, ensuring drug formulation homogeneity is vital for both safety and efficacy, especially during method transfer.…